BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2072768 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05197
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. PER THE COMPLAINT INFORMATION, THE PATIENT STATED THERE WAS AIR IN THE PATIENT LINE. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF A SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THERE WAS NOT ENOUGH DATA WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE OF THE AIR. THE LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL RELATED USER ERROR IN THE COMPLAINT. BAXTER FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    AFTER PRIMING AND WHILE CONNECTED, THE HOME PATIENT (HP) REPORTED SEEING AIR IN THE LINE. THE TSR EXPLAINED THAT THE HP WOULD NEED TO START OVER WITH NEW SUPPLIES AGAIN OR RISK INFECTION. THE HP WOULD START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE PRO